Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT02437500
Eligibility Criteria:
Main Inclusion Criteria:
1. Signed informed consent prior to initiation of any EAP-specific procedure or treatment. The subject, or their legally authorized representative, must be willing to provide written informed consent and understand the potential risks and benefits from EAP enrollment and treatment.
2. ≥2 episodes of CDI inclusive of the current episode
3. The CDI recurrence must have met the protocol definition of:
1. ≥3 unformed stools per day for 2 consecutive days
2. A positive C. difficile stool toxin assay or PCR test
3. CDI antibiotic therapy defined as either 10-21 days of vancomycin (125 mg po QID) or fidaxomicin (200 mg po BID). Pulse taper courses are also accepted.
4. An adequate clinical response to antibiotic therapy, defined as (\<3 unformed stools in 24 hours) for 2 or more consecutive days while on antibiotics.
5. The requirement that the subject can be dosed with study drug within 4 days of antibiotic completion.
Main Exclusion Criteria:
1. Female subjects who are pregnant, breastfeeding, lactating, or planning to become pregnant during the study.
2. Known or suspected toxic megacolon and/or known small bowel ileus.
3. Admitted to or expected to be admitted to an intensive care unit.
4. Absolute neutrophil count of \<500 cells/mm\^3.
5. Major gastrointestinal surgery (e.g., significant bowel resection or diversion) within 3 months before enrollment (this does not include appendectomy or cholecystectomy), or any history of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).
6. History of active inflammatory bowel disease (ulcerative colitis, Crohn's disease, microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel disease in the past 3 months.
7. Any history of fecal microbiota transplantation (FMT) in the past 3 months.
8. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with the study medical monitor).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02437500
Study Brief:
Protocol Section:
NCT02437500